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MONOCRYL recallZ-0487-2025 · Ethicon, Inc. · initiated Oct 8, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

FDA root cause category: Process control

What the company is doing

On 10/08/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" Letter via UPS 2nd Day Air to customers informing them that due to a manufacturing component error/mix, Monocryl Suture, Product Code Y936H, Lot TMMCQD may contain some packages with incorrect needle type/size and suture diameter/length. Customers are instructed to: 1. Examine inventory immediately and quarantine such product(s). Maintain/keep a copy of this notice with the quarantined product and your records. 2. Communicate the issue to relevant personnel, or anyone else who needs to be informed. If any product has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax 800-766-5841 or email [email protected] to Sedgwick within three business days. Return the BRF even if you do not have product subject to this recall. 4. Immediately return all unused Monocryl" (poliglecaprone 25) Suture subject to this recall (Product Code Y936H, Lot TMMDQD) in inventory. To receive replacement product, return product subject to this recall no later than December 31, 2024 to Sedgwick. Any non-affected product and any product returned after the date specified will not be eligible for credit reimbursement. 5. To return product, photocopy completed BRF, place in the box with the product, and affix the pre-paid authorized shipping label. Ethicon will pay for the shipping charges only if the authorized label is used. For extra shipping labels call Sedgwick at 888-203-3152. Your account number and mailing address have been pre-populated on the BRF. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. If you require any assistance with returning product, please contact Sedgwick at 888-203-3152 and reference Event # 2852.

Recall details

Recall number
Z-0487-2025
Status
Open, Classified
Initiated by the company
Oct 8, 2024
Posted by the FDA
Nov 19, 2024
Recalling firm
Ethicon, Inc.
Quantity
16,524 devices
Product code
GAN
FDA submissions
K964072
Distribution
U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.

Product description

MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.

Code information (models, lots, serial numbers)

Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

40 devices cleared under K964072 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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